With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Monday, September 30, 2013

The $3 billion California stem cell agency is predicting that
“human healthcare will be greatly improved” by stem cell research
by 2024 and this week is fleshing out some of the details of an
ambitious plan to help make that happen.

The staff document said a workshop earlier this year developed a
“consensus that it would be beneficial if the CIRM (the stem cell
agency) regulations reflected existing state and federal requirements
with regard to delegation of responsibility and avoid unnecessary
duplication of effort, such as the IRB (institutional review board)
responsibility for the risk and benefit assessment.”

The staff is recommending that “CIRM’s regulatory requirements
for clinical research should be modified to avoid duplication of
IRB’s responsibility for review and approval of clinical trials.”

The staff also said,

“CIRM’s existing regulatory requirements for notification,
review and approval of basic and pre-clinical research appear
effective at this time without creating undue burdens. In fact,
mature systems appear to be in place to efficiently incorporate ESCRO
(embryonic stem cell research oversight) operations into
institutional compliance programs.”

Also on the standards group agenda are issues dealing with
informed consent by providers of somatic cells “obtained under
general (biomedical) research protocols" in connection with iPSC (induced
pluripotent stem cell) derivation.

Dubbed the “Discuss Project,” its goal is “to initiate a
process designed to develop consensus for the use of previously
collected specimens for iPSC research" and to publish "final
considerations" in early 2014.

Another item on the agenda tomorrow involves an update on the
“progress of CIRM iPSC bank and donor consent protocol.”
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About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.